Mild Cognitive Impairment (MCI)NCT06735352
Effect of Vırtual Realıty Glasses on Mıld Cognıtıve Impaırment in Elderly
A study testing virtual reality intervention in people with Mild Cognitive Impairment (MCI), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted in a randomized controlled manner to investigate the effect of VR glasses on mild cognitive impairment in the elderly. The main questions the study aimed to answer are: Will VR improve mild cognitive impairment in the elderly? The researchers used a control group to compare the effect of VR on… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- virtual reality intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The study included elderly individuals who were over the age of 65,
- Diagnosed with MCI by a neurologist,
- Having a Standard Mini-Mental Statement (MMSE) score between 18 and 23,
- Having a Montreal Cognitive Assessment Scale (MOCA) score below 21,
- Able to communicate verbally,
- Agreeing to participate in the study.
Who cannot join
- The study excluded those with a history of stroke or epilepsy,
- Those with other suspected degenerative diseases or diagnosed severe psychiatric illnesses,
- Those with head trauma, thyroid disorders or other medical abnormalities that could impair cognitive function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vırtual Realıty Glasses on Mıld Cognıtıve Impaırment in Elderly: A Randomızed Controlled Study
This study was conducted in a randomized controlled manner to investigate the effect of VR glasses on mild cognitive impairment in the elderly. The main questions the study aimed to answer are:
- Will VR improve mild cognitive impairment in the elderly? The researchers used a control group to compare the effect of VR on mild cognitive impairment.
Participants:
- Before starting the study, the elderly were given the necessary forms and information.
- The elderly were shown virtual reality videos with VR glasses 3 days a week for 4 weeks.
- The control group did not watch any videos, and the post-test forms were filled out again for both groups at the end of 4 weeks.
Read the detailed description
The elderly population rate is rapidly increasing in the world and in our country. According to the World Health Organization (WHO) data, the elderly population aged 60 and over, which was 1 billion in 2019, is expected to increase to 1.4 billion in 2030 and 2.1 billion in 2050. In our country, the elderly population, which was 6 million in 2016, reached more than 8 million in 2023. (WHO 2021, TÜİK 2024). As life expectancy continues to increase, the number of elderly people who cannot live independently and need assistance due to cognitive decline is rapidly increasing worldwide (Díaz-Pérez \&, Flórez-Lozano, 2018; Huang \& Yang, 2022). Dementia is a collective name for a heterogeneous group of chronic neurodegenerative diseases characterized by progressive impairment of behavior and cognitive function (Aruanno \& Garzotto, 2019; D'Cunha et al., 2019). Mild Cognitive Impairment (MCI) is an intermediate stage of cognitive change between normal aging and dementia; the distinction between MCI and dementia is determined by the severity of cognitive decline leading to functional impairment. MCI, also known as the "symptomatic predementia stage," causes mild deterioration in cognitive function without significant loss of independent functional abilities, social and occupational functioning in individuals (Kim et al., 2019). MCI is defined as a condition in which individuals experience memory loss greater than expected for their age but do not meet the criteria for dementia. This is a less severe degree of cognitive impairment compared to dementia and is classified as Mild Cognitive Impairment in the DSM-5. However, the capacity for independence in activities of daily living and instrumental activities of daily living is preserved, unlike diseases such as dementia (Oliveira et al., 2021). According to WHO, there are approximately 55 million people with dementia worldwide; this number is expected to increase to 75 million by 2030 and approximately 135 million by 2050 (WHO, 2023). However, individuals with MCI typically have a higher risk of dementia than individuals of the same age without MCI (Petersen et al., 2018; Aruanno \& Garzotto, 2019; Kim et al., 2019). Although pharmacological interventions are recommended for the treatment of dementia types and MCI, polypharmacy in the elderly population can cause side effects. Therefore, new and effective non-pharmacological treatments are needed (Huang \& Yang 2022). Updated practice guidelines have indicated that exercise and cognitive interventions may be beneficial for improving cognitive functions in patients with MCI (Kim et al., 2019). Participation in stimulation of mental activities in older ages may be a protective factor against cognitive decline and possibly reduce the risk of developing dementia (Manera et al., 2016). Virtual reality (VR) is a new technology used for the rehabilitation of cognitive and motor functions (Tieri et al., 2018). VR is defined as a real or imaginary three-dimensional environment of computer simulation that allows its users to experience the feeling of being in a different physical place (D'Cunha et al., 2019). VR is a new branch of computer technologies that has recently been proposed for use in the field of neuropsychology. VR is a high-level computer interface that includes real-time simulation and interactions through multiple sensory channels, based on various perception components of psychophysics, primarily visual, tactile and kinesthetic perceptual sensations. The use of VR systems offers the opportunity to simulate immersive and interactive real-life scenarios to create a sense of "being there" (Zhu et al., 2021). The use of VR systems for disease treatment has already been investigated in various fields such as brain injury, post-stroke intervention, and musculoskeletal recovery. VR environments have also been used for neuropsychological assessment and problems such as phobias, stress, anxiety, exercise, and memory problems (Luque-Moreno et al., 2021; Manera et al., 2016). It has been reported that the use of VR for both stimulation and relaxation in people with cognitive decline reduces stress. These studies suggest that virtual reality can be used as a promising tool in many therapeutic and rehabilitation areas in MCI and dementia and have attracted the attention of researchers (Manera et al., 2016). Therefore, this study aimed to determine the effect of VR intervention on MCI in elderly individuals.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- virtual reality intervention
- Keywords
- elderly, virtual reality, mild cognitive impairment, nursing
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality interventionOther
Evaluated the effect of virtual reality use in elderly people with mild cognitive impairment compared to a control group.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No intervention was made to the elderly in this group. |
| virtual reality group | Experimental | Evaluated the effect of using virtual reality in elderly people with mild cognitive impairment. Receives: Other: virtual reality intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly Information Form
The study includes questions to determine the age, gender, marital status, education level and chronic disease status of elderly individuals.
Measured: 4 week
Mini-Mental State Examination
The MMSE, which provides assessment of cognitive status, was developed by Folstein and colleagues in 1975 and is the most commonly used and easily administered test in dementia screening (Folstein, 1975). Its validity and reliability in the diagnosis of mild dementia for the Turkish population was performed by Güngen and colleagues (Güngen 2002). The mini mental test is grouped under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is evaluated out of a total of 30 points and has two different types for the educated and the uneducated. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. A score between 18-23 points is considered mild dementia, 12-17 points is considered moderate dementia and 12 points below is considered severe dementia.
Measured: 4 week
Montreal Cognitive Assessment Scale
It is a screening scale developed specifically to evaluate the early stages of cognitive impairment. The scale evaluates attention and concentration, executive functions, memory, language, visual and spatial skills, abstract thinking, calculation and orientation functions. The test takes approximately 10 minutes. The visual structuring skills test is worth 5 points, the attention test is worth 6 points, the language (naming) test is worth 6 points, the abstract thinking test is worth 2 points, the delayed recall is worth 5 points and the orientation test is worth 6 points. Patients with 21 points and above out of 30 points are considered cognitively normal.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Dec 2023
- Primary completion15 Aug 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Buket DAŞTAN, Karadeniz Technical University
- Investigators
- Buket DAŞTAN, Ph.D, Principal investigator, Karadeniz Tecnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735352
- Sponsor's protocol ID
- RCS15102024
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I'll decide later
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vırtual Realıty Glasses on Mıld Cognıtıve Impaırment in Elderly: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06735352
- Acronym / sponsor ID
- RCS15102024
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- elderly, virtual reality, mild cognitive impairment, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted in a randomized controlled manner to investigate the effect of VR glasses on mild cognitive impairment in the elderly. The main questions the study aimed to answer are:
- Will VR improve mild cognitive impairment in the elderly? The researchers used a control group to compare the effect of VR on mild cognitive impairment.
Participants:
- Before starting the study, the elderly were given the necessary forms and information.
- The elderly were shown virtual reality videos with VR glasses 3 days a week for 4 weeks.
- The control group did not watch any videos, and the post-test forms were filled out again for both groups at the end of 4 weeks.
Detailed description
The elderly population rate is rapidly increasing in the world and in our country. According to the World Health Organization (WHO) data, the elderly population aged 60 and over, which was 1 billion in 2019, is expected to increase to 1.4 billion in 2030 and 2.1 billion in 2050. In our country, the elderly population, which was 6 million in 2016, reached more than 8 million in 2023. (WHO 2021, TÜİK 2024). As life expectancy continues to increase, the number of elderly people who cannot live independently and need assistance due to cognitive decline is rapidly increasing worldwide (Díaz-Pérez \&, Flórez-Lozano, 2018; Huang \& Yang, 2022). Dementia is a collective name for a heterogeneous group of chronic neurodegenerative diseases characterized by progressive impairment of behavior and cognitive function (Aruanno \& Garzotto, 2019; D'Cunha et al., 2019). Mild Cognitive Impairment (MCI) is an intermediate stage of cognitive change between normal aging and dementia; the distinction between MCI and dementia is determined by the severity of cognitive decline leading to functional impairment. MCI, also known as the "symptomatic predementia stage," causes mild deterioration in cognitive function without significant loss of independent functional abilities, social and occupational functioning in individuals (Kim et al., 2019). MCI is defined as a condition in which individuals experience memory loss greater than expected for their age but do not meet the criteria for dementia. This is a less severe degree of cognitive impairment compared to dementia and is classified as Mild Cognitive Impairment in the DSM-5. However, the capacity for independence in activities of daily living and instrumental activities of daily living is preserved, unlike diseases such as dementia (Oliveira et al., 2021). According to WHO, there are approximately 55 million people with dementia worldwide; this number is expected to increase to 75 million by 2030 and approximately 135 million by 2050 (WHO, 2023). However, individuals with MCI typically have a higher risk of dementia than individuals of the same age without MCI (Petersen et al., 2018; Aruanno \& Garzotto, 2019; Kim et al., 2019). Although pharmacological interventions are recommended for the treatment of dementia types and MCI, polypharmacy in the elderly population can cause side effects. Therefore, new and effective non-pharmacological treatments are needed (Huang \& Yang 2022). Updated practice guidelines have indicated that exercise and cognitive interventions may be beneficial for improving cognitive functions in patients with MCI (Kim et al., 2019). Participation in stimulation of mental activities in older ages may be a protective factor against cognitive decline and possibly reduce the risk of developing dementia (Manera et al., 2016). Virtual reality (VR) is a new technology used for the rehabilitation of cognitive and motor functions (Tieri et al., 2018). VR is defined as a real or imaginary three-dimensional environment of computer simulation that allows its users to experience the feeling of being in a different physical place (D'Cunha et al., 2019). VR is a new branch of computer technologies that has recently been proposed for use in the field of neuropsychology. VR is a high-level computer interface that includes real-time simulation and interactions through multiple sensory channels, based on various perception components of psychophysics, primarily visual, tactile and kinesthetic perceptual sensations. The use of VR systems offers the opportunity to simulate immersive and interactive real-life scenarios to create a sense of "being there" (Zhu et al., 2021). The use of VR systems for disease treatment has already been investigated in various fields such as brain injury, post-stroke intervention, and musculoskeletal recovery. VR environments have also been used for neuropsychological assessment and problems such as phobias, stress, anxiety, exercise, and memory problems (Luque-Moreno et al., 2021; Manera et al., 2016). It has been reported that the use of VR for both stimulation and relaxation in people with cognitive decline reduces stress. These studies suggest that virtual reality can be used as a promising tool in many therapeutic and rehabilitation areas in MCI and dementia and have attracted the attention of researchers (Manera et al., 2016). Therefore, this study aimed to determine the effect of VR intervention on MCI in elderly individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No intervention was made to the elderly in this group. |
| virtual reality group | Experimental | Other: virtual reality interventionEvaluated the effect of using virtual reality in elderly people with mild cognitive impairment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- The study included elderly individuals who were over the age of 65,
- Diagnosed with MCI by a neurologist,
- Having a Standard Mini-Mental Statement (MMSE) score between 18 and 23,
- Having a Montreal Cognitive Assessment Scale (MOCA) score below 21,
- Able to communicate verbally,
Key exclusion criteria (3 listed)
- The study excluded those with a history of stroke or epilepsy,
- Those with other suspected degenerative diseases or diagnosed severe psychiatric illnesses,
- Those with head trauma, thyroid disorders or other medical abnormalities that could impair cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality interventionEvaluated the effect of virtual reality use in elderly people with mild cognitive impairment compared to a control group. | Other | virtual reality group |
Primary outcome
Elderly Information Form
Time frame: 4 week
The study includes questions to determine the age, gender, marital status, education level and chronic disease status of elderly individuals.
Mini-Mental State Examination
Time frame: 4 week
The MMSE, which provides assessment of cognitive status, was developed by Folstein and colleagues in 1975 and is the most commonly used and easily administered test in dementia screening (Folstein, 1975). Its validity and reliability in the diagnosis of mild dementia for the Turkish population was performed by Güngen and colleagues (Güngen 2002). The mini mental test is grouped under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is evaluated out of a total of 30 points and has two different types for the educated and the uneducated. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. A score between 18-23 points is considered mild dementia, 12-17 points is considered moderate dementia and 12 points below is considered severe dementia.
Montreal Cognitive Assessment Scale
Time frame: 4 week
It is a screening scale developed specifically to evaluate the early stages of cognitive impairment. The scale evaluates attention and concentration, executive functions, memory, language, visual and spatial skills, abstract thinking, calculation and orientation functions. The test takes approximately 10 minutes. The visual structuring skills test is worth 5 points, the attention test is worth 6 points, the language (naming) test is worth 6 points, the abstract thinking test is worth 2 points, the delayed recall is worth 5 points and the orientation test is worth 6 points. Patients with 21 points and above out of 30 points are considered cognitively normal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided. I'll decide later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket DAŞTAN, Ph.D principal investigator
Karadeniz Tecnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality intervention in people with Mild Cognitive Impairment (MCI), run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly Information Form (time frame: 4 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.